Health
NAFDAC blacklists firm, directors over regulatory violations
By Rotimi Agbana
The National Agency for Food and Drug Administration and Control has blacklisted Onifam Laboratories Limited, its Managing Director/Chief Executive Officer, all directors, and every affiliated or associated person and entity found to have participated in regulatory violations.
The agency announced the sanction in a press statement issued on Monday, signed by the Director-General/Chief Executive Officer, Prof. Mojisola Adeyeye, saying the blacklisting takes immediate effect following investigations that uncovered multiple breaches of regulatory requirements governing the pharmaceutical sector.
According to the agency, those affected by the blacklist are barred from participating, directly or indirectly, in any pharmaceutical business regulated by NAFDAC, including obtaining regulatory approvals or operating in various capacities within the industry.
The statement read, “The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Ltd, its Managing Director/Chief Executive Officer, all Directors, and all affiliated or associated persons and entities found to have participated in regulatory violations, with immediate effect.
“The decision follows extensive investigations which established that the company engaged in regulatory misrepresentation, misuse of NAFDAC approvals and certificates, improper registration and transfer of pharmaceutical products, and activities that circumvented established regulatory processes.
“These actions compromise product traceability, weaken accountability, and pose significant risks to public health, in violation of the NAFDAC Act, the Food, Drug and Related Products (Registration, etc.) Act, the Drug and Related Products Registration Regulations 2021, and other applicable regulatory guidelines.
“Consequently, the affected company and associated persons or entities are prohibited from participating, directly or indirectly, in any pharmaceutical business regulated by NAFDAC. This includes applying for or benefiting from any NAFDAC registration, licence, permit, certificate, or approval, as well as acting as manufacturers, importers, distributors, marketing authorisation holders, agents, representatives, consultants, promoters, or sponsors of any NAFDAC-regulated product in Nigeria.”
The agency further disclosed that the blacklist will remain valid till it states otherwise, stressing that it also reserves the right to implement further regulatory sanctions if need be.
“The blacklist shall remain in force until otherwise directed by NAFDAC Management. The Agency also reserves the right to take further regulatory, administrative, enforcement, and legal actions as necessary to safeguard public health and preserve the integrity of Nigeria’s medicines regulatory system.
“NAFDAC reiterates its commitment to maintaining the highest standards of regulatory compliance and urges all stakeholders in the pharmaceutical sector to adhere strictly to applicable laws and regulatory requirements. The Agency remains resolute in ensuring that only safe, quality, and properly regulated medical products are available to the Nigerian public”, the agency added.
NAFDAC has in recent years stepped up enforcement against pharmaceutical manufacturers, importers and distributors involved in regulatory infractions as part of efforts to eliminate substandard and falsified medicines from the Nigerian market.
The agency has consistently warned that operators who circumvent regulatory processes or misuse its approvals and certifications would face administrative, legal and criminal sanctions aimed at protecting public health and preserving the integrity of the country’s medicines regulatory system.
The development marks NAFDAC’s latest enforcement action as it intensifies efforts to strengthen oversight of the pharmaceutical industry, curb regulatory abuses and ensure that only safe, quality and properly regulated medicines are available to Nigerians.
